Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga

November 19, 2024 updated by: Yuan-Mei Liao, RN, PhD, National Yang Ming Chiao Tung University

Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga on Relieving Genitourinary Symptoms, and Improving Sexual Function and Quality of Life in Asian Women With Breast Cancer

This study aims to examine the effects of Pelvic Floor Muscle Training (PFMT) combined with yoga on relieving genitourinary symptoms, symptom-related quality of life, and improving sexual function in women with breast cancer. This study is a parallel randomized study with two groups. Women will be assigned to the experimental or control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. The control group will receive regular care. We collect relevant data from both groups at baseline and 4, 8, 12, and 24 weeks after baseline during the study period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted with the approval obtained from the Institutional Review Board (IRB) of MacKay Memorial Hospital. This parallel-two-group randomized experimental study including an experimental group and a control group examines the effects of pelvic floor muscle training (PFMT) combined with yoga on genitourinary symptoms, symptom-related quality of life, and sexual function. A sample of women with breast cancer experiencing ≥1 genitourinary symptom(s) will be recruited and assigned to an experimental group or a control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. We will provide the experimental group with 12 days of online group practice sections of PFMT and yoga (weekly 60-minute practice incudes yoga 40 minutes, PFMT 15 minutes, and reflection 5 minutes). We expect them to perform 36 days of home-based practice of PFMT and yoga with 3 days/week of yoga for 40 minutes and PFMT for 15 minutes. The control group will receive regular care and relevant educational materials after data collection. Information will be collected at five time points: baseline and 4, 8, 12, and 24 weeks after baseline. Generalized estimating equation procedures will be used to examine the effects of the intervention. We hypothesized that the experimental group will display more significant improvements in genitourinary symptoms, symptom-related influences, and sexual function than those shown in the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 10449
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 20-60 years
  • Women with a confirmed diagnosis of breast cancer (Stages I-III) for ≥3 months
  • Women who experience ≥1 genitourinary symptom(s)

Exclusion Criteria:

  • Women with other types of cancer diagnoses (e.g., endometrial cancer and ovarian cancer)
  • Women with inadequately managed chronic conditions (e.g., an individual with diabetes having HbA1c level >7%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
The experimental group will receive regular care and a 12-week program of pelvic floor muscle training (PFMT) and yoga
Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga
The experimental group participants will be instructed to perform the practice session four days a week. The four days per week practice times (PFMT 15 minutes/day; yoga 40 minutes/day.) will result in weekly practice times for pelvic floor muscle training (PFMT) of 60 minutes and for yoga of ≥150 minutes.
No Intervention: Control group
The control group will receive regular care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vulvovaginal Symptoms
Time Frame: Baseline
The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
Baseline
Vulvovaginal Symptoms
Time Frame: 4 weeks after baseline
The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
4 weeks after baseline
Vulvovaginal Symptoms
Time Frame: 8 weeks after baseline
The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
8 weeks after baseline
Vulvovaginal Symptoms
Time Frame: 12 weeks after baseline
The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
12 weeks after baseline
Vulvovaginal Symptoms
Time Frame: 24 weeks after baseline
The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
24 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary symptoms
Time Frame: Baseline
We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.
Baseline
Urinary symptoms
Time Frame: 4 weeks after baseline
We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.
4 weeks after baseline
Urinary symptoms
Time Frame: 8 weeks after baseline
We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.
8 weeks after baseline
Urinary symptoms
Time Frame: 12 weeks after baseline
We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.
12 weeks after baseline
Urinary symptoms
Time Frame: 24 weeks after baseline
We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.
24 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sexual function
Time Frame: Baseline
The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.
Baseline
Sexual function
Time Frame: 4 weeks after baseline
The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.
4 weeks after baseline
Sexual function
Time Frame: 8 weeks after baseline
The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.
8 weeks after baseline
Sexual function
Time Frame: 12 weeks after baseline
The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.
12 weeks after baseline
Sexual function
Time Frame: 24 weeks after baseline
The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.
24 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms
Time Frame: Baseline
The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.
Baseline
Quality of life and distress associated with pelvic floor symptoms
Time Frame: 4 weeks after baseline
The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.
4 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms
Time Frame: 8 weeks after baseline
The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.
8 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms
Time Frame: 12 weeks after baseline
The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.
12 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms
Time Frame: 24 weeks after baseline
The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.
24 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming Chiao Tung University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuan-Mei Liao, PhD, National Yang Ming Chiao Tung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24MMHIS120e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available on request due to privacy and ethical restrictions.

IPD Sharing Time Frame

Baseline and 4, 8, 12 weeks after baseline

IPD Sharing Access Criteria

Data are available on request due to privacy and ethical restrictions.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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